Nicotine patches are frequently used in smoking patients during their stay in the ICU in order to avoid tobacco's weaning symptoms which are likely to interfere with mechanical ventilation weaning.

Until now the effectiveness of this treatment has not been proven. The aim of this study (NICOREA study) is to determine if a difference exists on the duration of mechanical ventilation once patients receive or not a nicotine substitute.

One or two 15mg nicotine patch(es) applied from 6am to 10pm according to the patients tobacco dependence measured by the Fagerström scale.

Drug: Nicotine patch

One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days

Other Name: Nicorette

Placebo Comparator: Placebo

One or two patch(es) with placebo

Drug: Placebo

One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days

Other Name: Nicorette placebo

Detailed Description:

Six hundred mechanically ventilated patients are going to be enrolled to receive nicotine or placebo during a 24 month period in 14 centers in France.

Eligibility

Ages Eligible for Study:

18 Years to 80 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age between 18 et 80 yrs

SOFA score below or equal to 16 at randomization time

Patient expected to be mechanically ventilated for at least 24hrs

Patient known to be usually smoking more than 10 cigarettes per day according to her/him or to a next of kin

Consent obtained from the patient or a next of kin.

Exclusion Criteria:

Patients having been in the ICU for more than 72 hours or mechanically ventilated since more than 48 hours

Isolated brain trauma

Patients weaned from tobacco since more than 21 days

Patients smoking only pipe, cigars or cannabis

Chronic skin diseases (psoriasis, dermatitis, etc)

Patients receiving other products containing nicotine

Patients not understanding French

Patients with severe hearing deficiency

Mechanical ventilation weaning using an expert system

Disease with short term fatal issue

Pregnancy

Patient depending on other persons for most every day actions

Myocardial infarction within 3 months, ventricular arrhythmia's

Stroke during the 3 last months

Known hypersensibility to nicotine or patches

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104896